A confirmatory study examining the efficacy in a clinical setting
The efficacy of the Braster device was confirmed clinically in the prospective observational study: ThermaALG.
The main objective of the study was to compare the effectiveness in diagnostics and differentiation of pathologies in women’s breasts against standard diagnostic methods. The study was conducted in 2015–2016. The secondary objective of the study was to validate the system for automatic interpretation of thermographic images (Braster AI).
The study covered 274 patients assigned to the relevant cohorts: women under 50 years of age with an ultrasound result of BIRADS 4B–5, women over 50 years of age with an ultrasound result of BIRADS 4–5, and two control groups for women under and over 50 years of age, respectively, with an ultrasound result of BIRADS 1–2.
The main results of the ThermaALG study:
- In the group of women under 50, the sensitivity* of the method amounted to 81.5% (95%CI: 64.1; 92.6), and the specificity** to 87% (95%CI: 79.7; 92.4). C statistics amounted to 0.842 (95%CI: 0.761; 0.924).
- In the group of women above 50, the sensitivity of the method amounted to 77.8% (95%CI: 67.2; 86.2), and the specificity to 62.5% (95%CI: 48.5; 75.1). C statistics amounted to 0.701 (95%CI: 0.617; 0.786).
- No adverse or primary adverse events were recorded in the study, which confirms the total safety of the researched technology.
*The likelihood of obtaining a positive result of the diagnostic test among ill patients. Higher sensitivity = overlooking fewer ill patients.
** The likelihood of obtaining a negative result of the diagnostic test among patients not suffering from the diagnosed disease. Higher specificity = fewer healthy patients incorrectly identified as ill.